Erector Spinae Plane Block for Congenital Hip Dislocation Surgery
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03949686 |
|
Recruitment Status :
Completed
First Posted : May 14, 2019
Last Update Posted : July 22, 2020
|
Sponsor:
Ataturk University
Information provided by (Responsible Party):
Ali Ahiskalioglu, Ataturk University
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed during this surgical treatment and cause severe postoperative pain. The aim of this study was to evaluate the analgesic effect of ultrasound guided erector spinae plane block (ESP) in pediatric patients undergoing CHD surgery.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Congenital Hip Dysplasia | Drug: Saline Solution Drug: Bupivacaine | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Erector Spinae Plane Block for Congenital Hip Dislocation Surgery: Randomized Controlled Double Blind Study |
| Actual Study Start Date : | April 22, 2019 |
| Actual Primary Completion Date : | January 1, 2020 |
| Actual Study Completion Date : | February 1, 2020 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Sham Comparator: Saline + Placebo
Ultrasound guided 0.5 ml/kg saline injection to erector spinae plane
|
Drug: Saline Solution
0.5 ml/kg saline
Other Name: saline |
|
Active Comparator: ultrasound guided erector spinae plane block
Ultrasound guided 0.5 ml/kg % 0.250 bupivacaine injection to erector spinae plane
|
Drug: Bupivacaine
0.5 ml/kg %0.25 bupivacaine |
Primary Outcome Measures :
- Face, Legs, Activity, Cry and Consolability Score (FLACC) [ Time Frame: Postoperative first 24hour ]FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Secondary Outcome Measures :
- Need for rescue analgesic [ Time Frame: 2 hour ]Number of patients who required rescue analgesia in postoperative care unit in the first 2 hour
- Need for analgesic [ Time Frame: 24 hour ]Number of patients who required analgesic in the first 24 hour
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 1 Year to 5 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- American Society of Anesthesiologist's physiologic state I-II patients undergoing hip dislocation surgery
Exclusion Criteria:
- chronic pain
- bleeding disorders
- renal or hepatic insufficiency
- patients on chronic non-steroidal anti-inflammatory medications
- emergency cases
- Incomplete patient forms
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- ASA III-IV
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949686
Locations
| Turkey | |
| Ataturk University | |
| Erzurum, Turkey, 25100 | |
Sponsors and Collaborators
Ataturk University
Publications:
| Responsible Party: | Ali Ahiskalioglu, Principal Investigator, Ataturk University |
| ClinicalTrials.gov Identifier: | NCT03949686 |
| Other Study ID Numbers: |
AUTF ANESTHESIA6 |
| First Posted: | May 14, 2019 Key Record Dates |
| Last Update Posted: | July 22, 2020 |
| Last Verified: | July 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Ali Ahiskalioglu, Ataturk University:
|
Postoperative Analgesia Ultrasound guided erector spinae plane block |
Additional relevant MeSH terms:
|
Hip Dislocation Developmental Dysplasia of the Hip Hip Dislocation, Congenital Joint Dislocations Joint Diseases Musculoskeletal Diseases Wounds and Injuries Hip Injuries Musculoskeletal Abnormalities |
Congenital Abnormalities Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |